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Device Name: Auxein Nailing System are categorized to the following system:

1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Gamma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System

INDICATION FOR USE:

1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures.

6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.

Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm.

Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm.

Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm.

Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm.

Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below.

1. Inner Screwdriver, Hex 4.0mm
2. Inner Screw Holder, Hex 4.0mm
3. Container for AJAX Cephalic Screw Instrument Set

These implants will be supplied in Sterile State (Gamma Irradiation) Only.

The provided text is a 510(k) summary for the Auxein Nailing System, which is a medical device. This type of document is for premarket notification of a device to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on comparing the new device to existing ones based on design, materials, and intended use, and generally does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics like sensitivity/specificity derived from such studies.

Therefore, many of the requested items, which are typical for studies involving AI algorithms or comparative effectiveness of diagnostic devices, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance beyond compliance with material and performance standards. The "performance" is demonstrated through adherence to these standards and comparison to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The testing described is non-clinical (material and mechanical), not involving human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of clinical expert consensus is not relevant to the non-clinical testing performed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not an AI device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing is compliance with established engineering and material standards (e.g., ASTM F136 for material composition, ASTM F543 for mechanical properties).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI training set for this device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no AI training set for this device.

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The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.

Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.

The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.

This 510(k) summary describes a submission for an infusion pump, which is a Class II medical device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or specific acceptance criteria with quantifiable performance metrics typically seen in AI/ML device submissions.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be definitively answered from the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in table format. The evaluation focused on non-clinical tests to verify that design modifications met "documented performance and safety requirements."

• Acceptance Criteria (Implicit): The device (ambIT® PreSet Ambulatory Infusion Pump) must perform safely and effectively for volumetric delivery of medicines/fluids at preset rates and volumes, similar to its predicate devices, particularly the Palm Pump (K002434), and meet all design requirements following software and PCB modifications.
• Reported Device Performance: "All tests will be conducted according to written test protocol, with defined test expectations and documented conclusions." The document claims that "documented verification and validation testing were defined and conducted... to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device." However, no specific performance values (e.g., accuracy of flow rate, battery life, alarm effectiveness) are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to "verification and validation testing" but does not indicate a sample size for any specific clinical or non-clinical test sets.
• Data Provenance: Not specified. The testing was conducted by Sorenson Medical, Inc.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. This device is an infusion pump, and its assessment focuses on engineering performance and safety rather than interpretative tasks requiring expert-established ground truth (like in medical imaging or diagnostic algorithms).

4. Adjudication Method for the Test Set:

Not applicable for a device of this nature. The "testing" referred to is performance and safety verification of the pump's mechanical and software functions, not interpretative data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret medical data, and the AI's impact on their performance is evaluated. This is an infusion pump, which does not involve human interpretation of complex medical data during its primary function.

6. If a Standalone Performance Study Was Done:

The document mentions "documented verification and validation testing were defined and conducted" to verify the design modifications met performance and safety requirements. This implies standalone testing related to the device's functional performance (e.g., accuracy of drug delivery, reliability of software). However, the specific methodology or quantitative results of such standalone functional testing are not detailed in this summary. The focus is on demonstrating substantial equivalence via design modifications and non-clinical testing.

7. Type of Ground Truth Used:

For an infusion pump, "ground truth" would relate to its engineering specifications and the accurate delivery of fluids.

• Ground Truth (Implicit): The ground truth for this device would be established by:
  • Engineering Specifications: Pre-defined standards for flow rate accuracy, pressure limits, alarm thresholds, battery performance, etc.
  • Bench Testing/Metrology: Using calibrated equipment to measure pump output, confirm programmed rates, and verify safety features against these specifications.
  • Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (e.g., Palm Pump K002434) serve as a de-facto "ground truth" or benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The device is a traditional electro-mechanical infusion pump with software.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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